BE PHARMACEUTICALS AG: Drug Recall
Recall #D-1148-2023 · 09/05/2023
Class II: Risk
Recall Details
- Recall Number
- D-1148-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- BE PHARMACEUTICALS AG
- Status
- Terminated
- Date Initiated
- 09/05/2023
- Location
- Zug, Switzerland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,148 vials
Reason for Recall
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Product Description
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
Distribution Pattern
Nationwide in the USA
Other Recalls by BE PHARMACEUTICALS AG
- Class II: Risk 01/10/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.